Omega Diagnostics (LSE:ODX) has completed the final stage of the CE marking procedure for its VISITECT Covid-19 antigen testing kit. The submission process was running in parallel with a useability study by Ulster University. This study has now been completed, and the CE marking application submitted.
A CE marked product indicates that the manufacturer has met all regulatory and safety requirements to distribute its products throughout Europe. For a healthcare company like Omega Diagnostics, receiving regulatory approval for its products is a must.
VISITECT has already been CE marked for professional use. However, this latest application is to allow individuals to self-test. The approval of home usage significantly expands the firm’s reach and addressable market size. Consequently, if it’s granted, the Omega Diagnostics revenue stream is set to grow rapidly.
How does this impact the ODX share price?
Following this announcement, the ODX share price only increased slightly by around 1%. Why? Because the submission of an application does not guarantee approval. The application reviewing process typically takes four to six weeks.
Should regulators not be satisfied with VISITECT, Omega Diagnostics will have to spend more time developing and improving its product to meet regulatory requirements. This delay will likely have a negative impact on the stock and potentially create an opportunity for competitors. However, if the Covid-19 testing kit is approved for home use, the ODX share price may begin to rise considerably.
The post Omega Diagnostics completes Covid-19 testing kit submission appeared first on The Motley Fool UK.
Adventurous investors like you won’t want to miss out on what could be a truly astonishing opportunity…
You see, over the past three years, this AIM-listed company has been quietly powering ahead… rewarding its shareholders with generous share price growth thanks to a carefully orchestrated ‘buy and build’ strategy.
And with a first-class management team at the helm, a proven, well-executed business model, plus market-leading positions in high-margin, niche products… our analysts believe there’s still plenty more potential growth in the pipeline.
Here’s your chance to discover exactly what has got our Motley Fool UK investment team all hot-under-the-collar about this tiny £350+ million enterprise… inside a specially prepared free investment report.
But here’s the really exciting part… right now, we believe many UK investors have quite simply never heard of this company before!
Zaven Boyrazian has no position in any of the shares mentioned. The Motley Fool UK has no position in any of the shares mentioned. Views expressed on the companies mentioned in this article are those of the writer and therefore may differ from the official recommendations we make in our subscription services such as Share Advisor, Hidden Winners and Pro. Here at The Motley Fool we believe that considering a diverse range of insights makes us better investors.